Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises

NCT ID: NCT03999177

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2019-09-01

Brief Summary

Correct performance of therapeutic lymphatic exercises has the potential to relieve lymphedema symptoms and optimize limb volume and lymph fluid level, in turn to improve breast cancer survivors' quality of life and reduce the risk of lymphedema. Kinect-TOLF (Kinect-Enhanced The-Optimal-Lymph-Flow Training System) is an innovative intelligent Kinect-enhanced training system to teach patients to perform the lymphatic exercises correctly. The Kinect-TOLF training system is not a medical device but a computer/mobile and motion-sensor program that helps patients to perform the lymphatic exercises correctly. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. The goal of the proposed project is to evaluate the usability and feasibility of Kinect-TOLF.

Conditions

Breast Cancer; Lymphedema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Kinect-TOLF prototype

Group Type: EXPERIMENTAL

Kinect-TOLF Training System

Intervention Type: BEHAVIORAL

This system will teach patients to perform the lymphatic exercises correctly. Like playing the video games, patients follow the avatar model in the video to perform the lymphatic exercises. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. Patients will be asked to conduct two types of usability testing: heuristic evaluation and end-user testing.

Interventions

Kinect-TOLF Training System

This system will teach patients to perform the lymphatic exercises correctly. Like playing the video games, patients follow the avatar model in the video to perform the lymphatic exercises. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. Patients will be asked to conduct two types of usability testing: heuristic evaluation and end-user testing.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women who have received surgical treatment for breast cancer (Stage I-III), including mastectomy, lumpectomy, sentinel lymph node biopsy (SLNB), SLNB plus lymph node dissection or axillary lymph nodes dissection
• Report any persistent or intermittent pain or lymphedema symptoms in the ipsilateral upper limb or body at least 8 weeks after surgery, that is, beyond the expected period of healing
• May or may not have had neoadjuvant therapy or adjuvant therapy of chemotherapy or radiation
• Have history or no history of lymphedema or have or not been treated for lymphedema;
• Able to speak and understand English since the proposed usability testing is designed to only test the English version of the intervention.
• Women willing to come to the NYU Perlmutter Cancer Center for the research visit.

Exclusion Criteria

• Women diagnosed with breast cancer but did not undergo surgical treatment as breast surgery and removal of lymph nodes are the major treatment-related risk factors for lymphedema;
• Known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions;
• Women with renal or heart failure, cardiac pacemaker or defibrillator, artificial limbs, or pregnant women as accurate measurement of body mass index (BMI) may not be possible with an impedance device according to the manufactures.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mei Fu, PhD, RN, FAAN

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

Fu MR, McTernan ML, Qiu JM, Ko E, Yazicioglu S, Axelrod D, Guth A, Fan Z, Sang A, Miaskowski C, Wang Y. The Effects of Kinect-Enhanced Lymphatic Exercise Intervention on Lymphatic Pain, Swelling, and Lymph Fluid Level. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211026757. doi: 10.1177/15347354211026757.

Reference Type: DERIVED

PMID: 34160294 (View on PubMed)

Other Identifiers

1R01CA214085

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-00222

Identifier Type: -

Identifier Source: org_study_id